Comparison of clinical efficacy of hyperbaric levo-bupivacaine (0.5%) with hyperbaric ropivacaine(0.75%) in infraumbilical surgeries under spinal anaesthesia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessing the time of onset of sensory blockade and time of onset of motor blockade after subarachnoid injection of the study drugs (hyperbaric levo-bupivacaine and hyperbaric ropivacaine) and comparing the data.
研究概览
简要总结
This study is aimed at comparing the clinical efficacy of two local anaesthetic drugs which have been already marketed in India i.e hyperbaric levobupivacaine (0.5%) and hyperbaric ropivacaine (0.75%) . Study will include two groups of patients with sample size of 30 in each group. Informed and written consent will be taken from each participant. Study will include ASA grade 1 and 2 patients who have been posted for infraumbilical surgeries under spinal anaesthesia. Data will be collected and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade 1 and Grade 2 patients posted for infraumbilical surgeries.
排除标准
- •Age less than 18 years and more than 60 years.
- •ASA Grade 3 and above patients.
- •Patient allergic to the interventional drugs.
- •Patient not willing to participate in the research.
- •Patient having any neurological disease linked with brain and spinal cord.
结局指标
主要结局
Assessing the time of onset of sensory blockade and time of onset of motor blockade after subarachnoid injection of the study drugs (hyperbaric levo-bupivacaine and hyperbaric ropivacaine) and comparing the data.
时间窗: At one minute interval after administation of study drugs till 20 minutes.
次要结局
- Assessment of the time required for two segments regression & complete regression of sensory blockade & complete regression of motor blockade in the two groups receiving the study drugs & time of first rescue analgesia requirement in the two groups will be done. Haemodynamic variations caused by the study drugs in the two groups will be noted. The quality of post operative analgesia in the two groups will be assessed & any adverse effects caused by the study drugs in the two groups will be noted. Data will be collected & compared.
研究者
Dr Manoj Panchal
Pandit BD Sharma PGIMS Rohtak